Your Ad Here


Micro and Nanotechnologies are Revolutionizing Medicine - BioFinger System and Adonis Project
  'Almost invisible' tools are being developed by European researchers to discover diseases earlier and to treat patients better. The miniaturization of instruments to micro and nano- dimensions promises to make our future lives safer and cleaner. A team of European researchers from the Fraunhofer Institute for Biomedical Technologies Institute near Saarbruecken is using nanotechnology to improve diagnostic capabilities. In the "Adonis"-project, nano-sized gold particles are used to detect prostate cancer cells at an early stage.





Polyketals
 

Delivery Confirmation: Biodegradable Polymers Show Promise for Improving Treatment of Acute Inflammatory Diseases

 

A family of biodegradable polymers called polyketals and their derivatives may improve treatment for such inflammatory illnesses as acute lung injury, acute liver failure and inflammatory bowel disease by delivering drugs, proteins and snips of ribonucleic acid to disease locations in the body.

 

Niren Murthy, an assistant professor in Georgia Tech’s Department of Biomedical Engineering, has developed biodegradable polymers that may improve the treatment of acute inflammatory illnesses. 

 

 “The polyketal microparticles we developed are simply a vehicle to get the drugs inside the body to the diseased area as quickly as possible,” said Niren Murthy, assistant professor in the Coulter Department of Biomedical Engineering at Georgia Tech and Emory University. “The major advantage to using these polyketals to deliver drugs is that they degrade into biocompatible compounds that don’t accumulate in a patient’s tissue or cause additional inflammation.”

 

Details about the polyketals and clinical applications were described during three presentations on August 18-20 at the 236th American Chemical Society National Meeting in Philadelphia. This research – launched in 2003 – is funded by the National Science Foundation and the National Institutes of Health.

 

In a presentation on August 19, graduate student Scott Wilson detailed a new polyketal derivative aimed at enhancing the treatment of inflammatory bowel disease – an illness that causes the large and small intestines to swell.

 

The new polymer has the advantage of stability in both acids and bases. It degrades only in the presence of reactive oxygen species, which are present in and around inflamed tissue. Cell culture experiments have demonstrated that the microparticles degraded more rapidly in cells that overproduced superoxide, a reactive oxygen species.

 

 

Polyketal microparticles – used as a vehicle to deliver therapeutics to an affected region of the body –degrade into biocompatible compounds that don’t accumulate in a patient’s tissue or cause additional inflammation. 

Georgia Tech Photo: Gary Meek Dowload 300 dpi image

 

The researchers are currently collaborating with Didier Merlin, a professor in the Division of Digestive Diseases at Emory University, to investigate loading these polyketals with therapeutics to treat inflammatory bowel disease.

 

“We think these microparticles are going to be fantastic for oral drug delivery because they can survive the stomach conditions before they release their contents in the intestines,” noted Murthy.

 

Murthy’s group is also examining the use of polyketals to treat acute liver failure – a condition in which the liver stops functioning because macrophages in the liver create reactive oxygen species. One treatment is the delivery of superoxide dismutase, an enzyme that detoxifies superoxide. Incorporating the enzyme inside a polyketal – poly(cyclohexane-1,4-diyl acetone dimethylene ketal) – allows the enzyme to be released very quickly in an acidic environment.

 

“Patients with acute liver failure need drugs as soon as possible or else they’ll die,” said Murthy. “We’ve tailored the polyketal’s hydrolysis rates to deliver the drug in one or two days.”

 

Nick Crisp, professor of microbiology and immunology at the University of Rochester Medical Center, and Robert Pierce, currently head of anatomic pathology at Schering-Plough Biopharma and formerly of the University of Rochester Medical Center, are collaborating on this project. Georgia Tech, Emory and the University of Rochester have filed three patent applications on the polyketal drug delivery system.

 

To treat other illnesses, it may be necessary to deliver proteins to a diseased organ. In a presentation on August 18, Georgia Tech researchers described such a method, which was developed by Murthy, Michael Davis, an assistant professor in the Coulter Department of Biomedical Engineering, and graduate student Jay Sy.

 

 “Delivering proteins inside microparticles has been limited because getting the protein into the microparticles required organic solvents that frequently destroyed the proteins,” explained Murthy. “To overcome this problem, we developed a method of simply immobilizing the protein on the surface of the microparticles.”

 

The researchers incorporated a nitrilotriacetic acid-lipid conjugate into the polyketal. In a one-step procedure, they mixed the microparticles with the proteins and centrifuged them. That immobilized the proteins on the surface of the polyketals. Laboratory experiments conducted under physiological conditions have shown that half of the bound proteins were released within 24 hours.

 

Also in collaboration with Davis, the researchers are testing the ability of the protein-bound polyketals to treat heart attacks.

 

In the next few years, Murthy and his team of graduate students and collaborators plan to continue developing new polyketals and conducting efficacy tests in cell cultures and animal studies.

 

“In the past few years, we have developed methods to tailor the polyketal’s properties, which have already allowed us to target many different medical conditions, but our end goal is to test these treatments in humans,” noted Murthy.

 

 

Source: Georgia Tech Press Release




Gold Nanoparticles Speed Cancer Drug Delivery from Two Days to Two Hours Gold Nanoparticles Speed Cancer Drug Delivery from Two Days to Two Hours

--Paper discusses gold nanoparticle system that takes drug right to cancerous cells--

 

Researchers at Case Western Reserve University have developed a technique that has the potential to deliver cancer-fighting drugs to diseased areas within hours, as opposed to the two days it currently takes for existing delivery systems.

 

Using laboratory mice, drug delivery time from injection to the cancer cells was reduced from two days to mere hours. Using this as a model for potential human use, cancer patients may someday soon receive the benefits of cancer-fighting drugs within hours of injection. Findings are discussed in a paper, co-authored by Clemens Burda, associate professor of chemistry and director of the Center for Chemical Dynamics and Nanomaterials Research at Case Western Reserve University and graduate student Yu Cheng, appearing in the current edition of the Journal of the American Chemical Society .

 

The system uses gold nanoparticle vectors to deliver photodynamic therapy (PDT) drugs through the bloodstream to cancerous sites. "Gold nanoparticles are usually not used for the PDT drug vector," said Cheng. "However, gold is chemically inert and nontoxic."

 

Photodynamic therapy utilizes light-sensitive drugs that, when exposed to light of a certain wavelength, will energize and burn away cancer cells.

 Because exposure to light activates these drugs, PDT patients must keep out of bright lights for days while the drugs make their way through the bloodstream to the cancer site. At that time, they are activated by a light focused on the specific area of the body. "By shortening the waiting time from drug injection to activation, PDT patients are much less inconvenienced and tend to have a more normal lifestyle," said Burda.

 

Looks like a "Hairy Ball"

The drug delivery system uses a gold nanoparticle (Au NP) as its hub. Gold is non-toxic to the human body, and has a versatile surface chemistry, large surface-to-volume ratio and variable size and shape.

 

Each Au NP is coated with polyethylene glycol (PEG) ligands, giving it the appearance of a hairy ball, said Burda. These PEG molecules offer several advantages over other materials: they are soluble in fats and water, don't interact with proteins in the bloodstream and help protect the drug, keeping it safe and stable until delivery to the cancer site.

 

Between each PEG ligand, molecules of a photodynamic chemotherapy drug (Pc 4) are attached to the Au NP. The Pc 4 drug (a phthalocyanine compound) was developed at Case Western Reserve by Malcolm Kenney, professor of chemistry.

 

When the nanoparticle reaches the cancerous tissue the drug molecules are released and uploaded to the diseased area. Focused red light is used to energize the drug in the patient once it has been delivered to the tumor.

 

Burda says that a potential future research project would look at providing a time-release administration of the drug rather than a more all-at-once release. In the long term, Burda hopes to make the Au NP delivery system applicable to a broad range of diseases.

 

The Au NP has a diameter of 5 nm. The addition of PEG ligands expands the total diameter to 32 nm, larger than some other nanoparticles currently in use, but still small enough to pass unencumbered through the bloodstream.

 

A single 1/4-mL injection holds approximately 100 million Au NPs, each carrying approximately 100 drug molecules.

 

Tail to Tumor in Two Minutes

In the laboratory of Baowei Fei, assistant professor of radiology and biomedical engineering at Case Western Reserve, these Au NPs have been used to treat mice with cancerous tumors. Once the Au NPs have been injected into the tail, the Pc 4 is uploading into the diseased area within minutes. The accelerated speed of drug administration in mice is due in part to the much more efficient dispersion of the NP delivered drug.

 

When tested on human cells called HeLa — a line of laboratory-grown human cells used in testing — most of the drug is uploaded within one hour.

 

Testing on human beings may not begin for some time. Commercialization will take even longer due to Food and Drug Administration (FDA) testing and approval. However, all of the components — Au Nps, PEG ligands and Pc 4 — have already received FDA approval.

 

What's Next

Burda says that as Au NP testing continues, short-term goals include minimizing the amount of material and drug load needed for effective interaction with cancer cells; optimizing potential targeting systems on the PEG ligands for faster, even more specific placement in diseased areas; and increasing the overall effectiveness of nanoparticle enhanced therapy.

 

"The system is very modular," says Burda. "We can change the size and shape of the Au core NPs and we can change the functionality of the PEG ligands. This should lead to optimization of the drug targeting and therapy. If our research is successful, other researchers might adapt this drug delivery system to other diseases and applications."

 

Funding support came from the National Science Foundation, National Institute of Health/National Cancer Institute and the Biomedical Research Technology Transfer Center under the leadership of Pamela Davis, dean of the Case Western Reserve School of Medicine and vice president for medical affairs.

 

Source: Case Western University Press Release


Nanoparticles Aid Bone Growth-Nanotube-Reinforced Material Produces Denser Bone Tissue Nanoparticles Aid Bone Growth-Nanotube-Reinforced Material Produces Denser Bone Tissue

In the first study of its kind, bioengineers and bioscientists at Rice University and Radboud University in Nijmegen, Netherlands, have shown they can grow denser bone tissue by sprinkling stick-like nanoparticles throughout the porous material used to pattern the bone.

 

The research is available online and slated to appear in the journal Bone. It's the latest breakthrough from the burgeoning field of tissue engineering. The new discipline combines the latest research in materials science and biomedical engineering to produce tissues that can be transplanted without risk of rejection.

 

To grow new bone, tissue engineers typically place bone cells on porous, biodegradable materials called scaffolds, which act as patterns. With the right chemical and physical cues, the cells can be coaxed into producing new bone. As the scaffold degrades, it is replaced by new bone.

 

"Ideally, a scaffold should be highly porous, nontoxic and biodegradable, yet strong enough to bear the structural load of the bone that will eventually replace it," said lead researcher Antonios Mikos, Rice's J.W. Cox Professor in Bioengineering, professor of chemical and biomolecular engineering and the director of Rice's Center for Excellence in Tissue Engineering. "Previous research has shown that carbon nanotubes give added strength to polymer scaffolds, but this is the first study to examine the performance of these materials in an animal model."

 

In the experiments, the researchers implanted two kinds of scaffolds into rabbits. One type was made of a biodegradable plastic called poly(propylene fumarate), or PPF, which has performed well in previous experiments. The second was made of 99.5 percent PPF and 0.5 percent single-walled carbon nanotubes. Nanotubes are about 80,000th the width of a hair. While they are normally about a thousand times longer than they are wide, the researchers used shorter segments that have fared well in prior cytocompatibility studies.

 

Half the samples were examined four weeks after implantation and half after 12 weeks. While there was no notable difference in performance at four weeks, the nanotube composites exhibited up to threefold greater bone ingrowth after 12 weeks than the PPF. Furthermore, the researchers found the 12-week composite scaffolds contained about two-thirds as much bone tissue as the nearby native bone tissue, while the PPF contained only about one-fifth as much.

 

Mikos said the nanocomposites performed better than anticipated. In fact, the results indicate that they may go beyond passive guides and take an active role in promoting bone growth.

 

"We don't yet know the exact mechanism of this enhanced bone formation, but we have intensive studies under way to find out," Mikos said. "It could be related to changes in surface chemistry, strength or other factors."

 

Co-authors on the paper include Rice former Ph.D. graduate student Xinfeng Shi, now a research scientist at Bausch & Lomb, and former postdoctoral fellow Balaji Sitharaman, now an assistant professor of biomedical engineering at State University of New York at Stony Brook; Lon Wilson, professor of chemistry at Rice; and John Jansen, Frank Walboomers, Hongbing Liao and Vincent Cuijpers, all of Radboud University Nijmegen Medical Center.

 

The research was funded by the National Institutes of Health, the National Science Foundation, the Robert A. Welch Foundation, and Rice's J. Evans-Attwell Postdoctoral Fellows Program.


Nanominerals Influence Earth Systems from Ocean to Atmosphere to Biosphere
 

A bacteria cell living in a no-oxygen environment "breathes" using mineral nanoparticles

(Image Caption)

 

The ubiquity of tiny particles of minerals--mineral nanoparticles--in oceans and rivers, atmosphere and soils, and in living cells are providing scientists with new ways of understanding Earth's workings. Our planet's physical, chemical, and biological processes are influenced or driven by the properties of these minerals.

 

So states a team of researchers from seven universities in a paper published in the journal Science: "Nanominerals, Mineral Nanoparticles, and Earth Systems."

 

The way in which these infinitesimally small minerals influence Earth's systems is more complex than previously thought, the scientists say. Their work is funded by the National Science Foundation (NSF).

 

"This is an excellent summary of the relevance of natural nanoparticles in the Earth system," said Enriqueta Barrera, program director in NSF's Division of Earth Sciences. "It shows that there is much to be learned about the role of nanominerals, and points to the need for future research."

 

Minerals have an enormous range of physical and chemical properties due to a wide range of composition and structure, including particle size. Each mineral has a set of specific physical and chemical properties. Nanominerals, however, have one critical difference: a range of physical and chemical properties, depending on their size and shape.

 

"This difference changes our view of the diversity and complexity of minerals, and how they influence Earth systems," said Michael Hochella of the Virginia Polytechnic Institute and State University in Blacksburg, Va.

 

The role of nanominerals is far-reaching, said Hochella. Nanominerals are widely distributed throughout the atmosphere, oceans, surface and underground waters, and soils, and in most living organisms, even within proteins.

 

Nanoparticles play an important role in the lives of ocean-dwelling phytoplankton, for example, which remove carbon dioxide from the atmosphere. Phytoplankton growth is limited by iron availability. Iron in the ocean is composed of nanocolloids, nanominerals, and mineral nanoparticles, supplied by rivers, glaciers and deposition from the atmosphere. Nanoscale reactions resulting in the formation of phytoplankton biominerals, such as calcium carbonate, are important influences on oceanic and global carbon cycling.

 

On land, nanometer-scale hematite catalyzes the oxidation of manganese, resulting in the rapid formation of minerals that absorb heavy metals in water and soils. The rate of oxidation is increased when nanoparticles are present.

 

Conversely, harmful heavy metals may disperse widely, courtesy of nanominerals. In research at the Clark Fork River Superfund Complex in Montana, Hochella discovered a nanomineral involved in the movement of lead, arsenic, copper, and zinc through hundred of miles of Clark River drainage basin.

 

Nanominerals can also move radioactive substances. Research at one of the most contaminated nuclear sites in the world, a nuclear waste reprocessing plant in Mayak, Russian, has shown that plutonium travels in local groundwater, carried by mineral nanoparticles.

 

In the atmosphere, mineral nanoparticles impact heating and cooling. Such particles act as water droplet growth centers, which lead to cloud formation. The size and density of droplets influences solar radiation and cloud longevity, which in turn influence average global temperatures.

 

"The biogeochemical and ecological impact of natural and synthetic nanomaterials is one of the fastest growing areas of research, with not only vital scientific, but also large environmental, economic, and political consequences," the authors conclude.

 

In addition to Hochella, authors of the paper are Steven Lower of Ohio State University, and Patricia Maurice of the University of Notre Dame; along with R. Lee Penn of the University of Minnesota; Nita Sahai of the University of Wisconsin-Madison; Donald Sparks of the University of Delaware; and Benjamin Twining of the University of South Carolina.

 

Source: -NSF-

 

The National Science Foundation (NSF) is an independent federal agency that supports fundamental research and education across all fields of science and engineering, with an annual budget of $5.92 billion. NSF funds reach all 50 states through grants to over 1,700 universities and institutions. Each year, NSF receives about 42,000 competitive requests for funding, and makes over 10,000 new funding awards. The NSF also awards over $400 million in professional and service contracts yearly.

NSF Home Page: http://www.nsf.gov

 

Share your Favorite Biotech/Pharma/Medicine/Clinical Trials articles on Your Helix!-Professional Networking Site Designed for Biotech/Pharma Community:

Your Helix !


 

Novel Nanoparticle Drug Technology- rP-nano™

 

Nottingham, UK– Novozymes announced a new collaboration agreement with Upperton Limited, a UK based Biotech Company specializing in novel nanoparticle-based drug delivery systems. The agreement extends previous collaborations between the two companies and will focus on the commercial exploitation of the jointly-owned rP-nano™ technology: a highly targeted drug delivery system which utilizes the natural binding properties of recombinant protein nanoparticles to enhance drug and gene bioavailability.

 

rP-nano™ technology can produce nanoparticles from all peptides and proteins, including monoclonal antibodies and enzymes, without denaturation. The suitability of this technology to pharmaceutical applications will be demonstrated to potential licensees through nanoparticles generated from recombinant human albumin. Novozymes is the sole manufacturer of the worlds' only animal-free commercially available recombinant human albumin approved for use by the EMEA and FDA in the manufacture of human therapeutics, Recombumin®. For proof of principle, Upperton has loaded Novozymes' recombinant human albumin with monoclonal antibodies, radioactive metal ions, chemotherapeutic agents and paramagnetic metal ions.

 

Under the terms of the agreement Upperton will use rP-nano™ technology to generate nanoparticles from recombinant proteins expressed in Novozymes' proprietary, yeast-based expression system. Uniquely, rP-nano™ technology can generate precisely-sized nanoparticles within the range of 10nm to 120nm and can be optimized for Enhanced Permeability and Retention effect. The nanoparticles produced through this process retain the natural binding properties of the recombinant proteins from which they are made, and bind to specific cell types to enable more targeted drug delivery and improved bioavailability.

 

Dr Richard Johnson, MD Upperton Limited, said: "I am extremely pleased to be continuing our collaboration with Novozymes. Use of their animal-free, GMP recombinant proteins will be extremely important as we look to commercialise our unique technology. In addition, Novozymes' regulatory knowledge and expertise in yeast-based protein expression, will allow us to faster develop rP-nano™ technology and create a very attractive proposition for future marketing or licensing partners"

 

Dr Dave Mead, Novozymes' UK based Business Development Director commented: "Our original research demonstrated the huge potential of rP-nano™ technology and we are very pleased to continue collaborating with Upperton to develop this further. This is further exemplification of Novozymes' high yielding expression systems being used for the production of pharmaceutical grade recombinant proteins"

 

About Upperton Ltd.

Upperton Limited, founded in 1999, is a privately owned biotech company based in Nottingham, UK and specialising in spray drying and particle technologies. They have recently co-patented rP-nano™ technology with Novozymes as a next generation technology for producing nano-sized particles from proteins, with broad application. The rP-nano™ technology offers unique competitive advantages over current methods of producing nanoparticles. Upperton welcomes academic and industrial partners to explore and commercialise this technology.

 

Further information about Upperton can be found at www.upperton.com

 

About Novozymes

Novozymes is the world leader in bioinnovation. Together with customers across a broad array of industries, we create tomorrow's industrial biosolutions, improving our customers' business and the use of our planet's resources. With over 700 products used in 130 countries, Novozymes' bioinnovations improve industrial performance and safeguard the world's resources by offering superior and sustainable solutions for tomorrow's ever-changing marketplace.

 

Novozymes' natural solutions enhance and promote everything from removing trans-fats in food, to advancing biofuels to power the world tomorrow. Our never-ending exploration of nature's potential is evidenced by over 4,500 patents, showing what is possible when nature and technology join forces.

 

Our 4,500+ employees working in research, production and sales around the world are committed to shaping business today and our world tomorrow.

 

Read more at www.biopharmaceuticals.novozymes.com .

 

Source: Upperton Press Release



Share your Favorite articles on the following Social Networks:

Share on Facebook StumbleUpon Digg!


 

Nanodiamonds: New Horizon in Nanomaterials

e-published on MedicineandBiotech.com November 1st, 2007

 

With the recent developments in Nanoscience and Nanotechnology, carbon-based Nanomaterials (e.g., fullerenes, nanotubes, nanodiamonds) are attracting great interest for biological and medical  applications. Nanodiamonds display remarkable mechanical, electrical, and thermal properties. Owing to their low chemical reactivity and unique physical properties, Nanodiamonds can be useful in a variety of biological applications such as:

  1. carriers for drugs, genes, or proteins
  2.  novel imaging techniques
  3. coatings for corrosion resistant implantable medical devices
  4. biosensors/biochips
  5. biomedical nanorobots
  6. purification of proteins
  7. many other emerging biomedical techniques

 Therefore, it is essential to ascertain the safety and efficacy of Nanodiamonds to humans and living cells. Finely divided carbon particles, including charcoal, lampblack, and diamond particles, have been used for ornamental and official tattoos since ancient times. Studies have assessed the cytotoxicity of nanodiamonds ranging in size from 2 to 10 nm. Assays of cell viability such as mitochondrial function (MTT) and luminescent ATP production showed that nanodiamonds were not toxic to a variety of cell types. Furthermore, nanodiamonds did not produce significant reactive oxygen species. Cells can grow on nanodiamond-coated substrates without morphological changes compared to controls. These results suggest that nanodiamonds could be ideal for many biological applications in a diverse range of cell types.

 

It is envisaged that nanodiamonds may prove to be an even better drug carrier, imaging probe, or implant coating in biological systems compared to currently used nanomaterials due to its optical transparency, chemical inertness, high specific area, and hardness.

 

Recent progresses in the dispersion of detonation nanodiamonds (2-10 nm) in aqueous media has facilitated the use of nanodiamonds in physiological solutions, whereas most previous studies have focused on polycrystalline chemical vapor deposited (CVD) diamond films for biomedical applications. The availability of the newly produced detonation nanodiamonds in aqueous dispersed forms facilitates their possible use in nanomedicine (e.g., medical nanorobots) and biorelated studies. However, the environmental impact of the detonation nanodiamonds, especially on humans and other biological systems needs to be further evaluated.

 

Researchers have visualized  diamond nanoparticles with fluorescent confocal microscopy to enter the cells and localize in the cytoplasm. For these nanodiamonds to be fluorescent, however, they performed the tedious procedures of electron beam irradiation and annealing of the nanoparticles. At the nanometer scale, the particle properties depend strongly on the size of the material.

 

One of the key avenues to understanding how biological systems function at the molecular level is to probe biomolecules individually and observe how they interact with each other directly in vivo. However, in applying this technique to imaging and tracking a single molecule or particle in a biological cell, progress is often hampered by the presence of internal interference from ubiquitous endogenous components such as flavins, nicotinamide adenine dinucleotides, collagens, and porphyrins that produce high fluorescence background signals. Fluorescent semiconductor nanocrystals (or quantum dots), on the other hand, have gained considerable attention in recent years because they hold a number of advantageous features including high photobleaching thresholds and broad excitation but narrow emission spectra well suited for multicolor labeling and detection. Unfortunately, most nanomaterials are toxic, and hence reduction of cytotoxicity and human toxicity through surface modification is key in successful applications of quantum dots to in vivo labeling, imaging, and diagnosis.

 

Hence, the use of Fluorecent Nanodiamonds offers a more safer, reliable tool for in vivo studies as a drug or gene carrier, as a device for tumor targeting, and as a fluorescent probe for two-photon confocal microscopy. Developed originally for surface finishing industry, the diamond nanoparticles now have new and far-reaching applications in modern biomedical science and biotechnologies.



Share your Favorite articles on the following Social Networks:


Share on Facebook StumbleUpon Digg!



FDA Readies for 'Nanoscale' Challenges
Credit: FDA Consumer Health Information; Image source: National Cancer Institute
e-published on MedicineandBiotech.com September 1st, 2007

Nanotechnology is changing the way many FDA-regulated products will be made. In the

interest of promoting and protecting the public health, FDA will work to clarify what

information will be needed in its efforts to oversee products that contain nanoscale materials

—those created at sizes as small as 100,000th the width of a human hair.

 

FDA's Nanotechnology Task Force released a report on July 25, 2007, that recommends the

 agency consider developing guidance and taking other steps to address the benefits and risks

 of drugs and medical devices using nanotechnology.

 

Commissioner of Food and Drugs Andrew von Eschenbach, M.D., endorsed the Task

Force Report and its recommendations."Nanotechnology holds enormous potential for

use in a vast array of products," he said. "Recognizing the emerging nature of this

technology and its potential for rapid development, this report fosters the continued

development of innovative, safe and effective FDA-regulated products that use

nanotechnology materials.

 

Nanotechnology Today

Nanotechnology is currently used in such fields as display technology for laptop computers,

cell phones, and digital cameras, and in water filtration. And nanomedicine is an area of

biomedical research that seeks to use nanoscale tools to improve health.

Current medical uses of nanotechnology include:

 

      * burn and wound dressings

      * a dental-bonding agent

      * sunscreens

      * protective and glare-reducing coatings for eyeglasses

 

 

Nanotechnology Tomorrow

Some day, you may see nanotechnology used in food packaging to further extend shelf life

or used medically to:

* provide new drugs that are able to reach sites in the body more effectively and

at safer doses.

* create tiny sensors that detect diseases in the body far earlier than existing

diagnostic tools

* manufacture incredibly small pumps that can be implanted to deliver lifesaving

medications precisely to the cells and tissues that   need them.

 

Regulation Strategies

For the most part, FDA experts believe that nanotechnology products present challenges

similar to those FDA faces for products of other emerging technologies. FDA experts

recognize, however, that product safety and effectiveness can change as size goes up or

down within the nanoscale, adding additional complexity to the product review. It’s also

possible that nanotechnology will be used in a wide variety of products, such as foods,

drugs, cosmetics, and medical devices.

 

The agency expects that many of the nanotechnology products it will regulate will span

the regulatory boundaries between drugs, medical devices, and biologics. These, then,

would be regulated under the rules established for "combination products."

 

For More Information

http://www.fda.gov/nanotechnology/

FDA's July 25, 2007 Nanotechnology Press Release
http://
www.fda.gov/bbs/topics/NEWS/2007/NEW01671.html  

 



Share your Favorite articles on the following Social Networks:

Share on Facebook StumbleUpon Digg!



Nanotechnology Report from FDA
 

---FDA Nanotechnology Report Outlines Scientific, Regulatory Challenges---

 

July 25, 2007. The U.S. Food and Drug Administration (FDA)'s Nanotechnology Task Force today released a report that recommends the agency consider developing guidance and taking other steps to address the benefits and risks of drugs and medical devices using nanotechnology.

 

"Nanotechnology holds enormous potential for use in a vast array of products," said Commissioner of Food and Drugs Andrew von Eschenbach, M.D., who endorsed the Task Force Report and its recommendations on July 23, 2007. "Recognizing the emerging nature of this technology and its potential for rapid development, this report fosters the continued development of innovative, safe and effective FDA-regulated products that use nanotechnology materials."

 

Scientists and researchers increasingly are working in the nanoscale, creating and using materials and devices at the level of molecules and atoms—1/100,000th the width of a human hair.

 

The FDA's Task Force Report on Nanotechnology addresses regulatory and scientific issues and recommends FDA consider development of nanotechnology-associated guidance for manufacturers and researchers. The Task Force was initiated by Commissioner von Eschenbach in 2006.

 

The Task Force reports that nanoscale materials potentially could be used in most product types regulated by FDA and that those materials present challenges similar to those posed by products using other emerging technologies. The challenges, however, may be complicated by the fact that properties relevant to product safety and effectiveness may change as size varies within the nanoscale.

 

The report also says that the emerging and uncertain nature of nanotechnology and the potentially rapid development of applications for FDA-regulated products highlight the need for ensuring transparent, consistent, and predictable regulatory pathways.

 

Anticipating the potential for rapid development in the field, the report recommends consideration of agency guidance that would clarify, for example, what information to give FDA about products, and also when the use of nanoscale materials may change the regulatory status of particular products. As with other FDA guidance, draft guidance documents would be made available for public comment prior to being finalized.

 

In addition, the report says the FDA should work to assess data needs to better regulate nanotechnology products, including biological effects and interactions of nanoscale materials. The agency also should develop in-house expertise and ensure consideration of relevant new information on nanotechnology as it becomes available, according to the report. FDA should evaluate the adequacy of current testing approaches to assess safety, effectiveness and quality of nanoscale materials.

 

FDA and 22 other federal agencies are part of the National Nanotechnology Initiative, a federal research and development program established to coordinate the multi-agency efforts in nanoscale science, engineering, and technology.

 

For more information:

 

FDA Nanotechnology Report

 

Report PDF: www.fda.gov/nanotechnology/taskforce/report2007.pdf

 

Report HTML: www.fda.gov/nanotechnology/taskforce/report2007.html

 

Consumer Article: www.fda.gov/consumer/updates/nanotech072507.html

 

National Nanotechnology Initiative: http://www.nano.gov/ 

 

Fact sheet: http://www.fda.gov/nanotechnology/taskforce/factsheet2007.html  




FIRST-EVER FORTUNE iMEME CONFERENCE TO CONVENE TOP TECH AND MEDIA LEADERS IN SAN FRANCISCO FIRST-EVER FORTUNE iMEME CONFERENCE TO CONVENE TOP TECH AND MEDIA LEADERS IN SAN FRANCISCO

i = information

Meme = a unit of cultural information that is transferable from one mind to another. It is self-propagating as a unit of cultural evolution and diffusion. Often, memes propagate as more or less integrated, cooperative sets or groups, analogous, in many ways, to the behavior of genes. Memes that replicate most effectively spread best. 

This summer a select group of leaders and innovators will come together to share the ideas they consider the digital memes driving the future at FORTUNE iMeme: The Thinkers of Tech. This invitation-only event is for business executives who recognize that their company's future depends on understanding the trends at the core of technology. Topics—ranging from the purely technological to the cultural—will include the platforms of the future, the challenges tech and telecom face as the connected world expands, the future of digital media, the Internet's next act, the impact of green technology, how to market to the entire planet, and upcoming digital disruptors.

FORTUNE's tech conference is sponsored by the magazine's technology, media, and Internet editorial talent and chaired by technology editor David Kirkpatrick. The conference will offer an in-depth perspective on the current digital landscape, a glimpse into the future, and a vision of how your company can capitalize on technology's transformative effects. iMeme promises an unparalleled combination of energy, imagination, and digital-age combustion.

Event:              FORTUNE iMEME: The Thinkers of Tech Conference

Dates:               Thursday, July 12 & Friday, July 13

Location:          The Ritz-Carlton, San Francisco

                           600 Stockton Street at California Street

                           San Francisco, CA 94108                                      

*Program is subject to change.  For an updated agenda please check:

http://www.timeinc.net/fortune/conferences/imeme/imeme_home.html

 Speakers below are confirmed as of July 2, 2007.

 Time:   Thursday, July 12

 7:00 am—9:00 am – PRESS REGISTRATION

 

9:00 am—9:05 am – WELCOMEAndy Serwer, Managing Editor, FORTUNE; David Kirkpatrick, Technology Editor, FORTUNE

 

9:05 am—9:50 am – iMEME: ECOSYSTEMS – PLATFORMS FOR THE NEXT NET - Marc Benioff, CEO, salesforce.com; Marissa Mayer, Vice President, Search Products and User Experience, Google; Philip Rosedale, CEO, Linden Lab; Mark Zuckerberg, CEO, Facebook; Moderator: David Kirkpatrick, FORTUNE

9:50 am—10:00 am – “MY MEME”: A SHORT TALK ON WHAT MATTERS - Introduced by James Ledbetter, CNNMoney.com; Catherine Cook, Co-founder, myYearbook.com

 

10:00 am—10:50 am – iMEME: COMMUNICATE – WHO MOVES THE BITS? - Lou D’Ambrosio, CEO, Avaya; Lisa Hook, CEO, SunRocket; Paul Jacobs, CEO, QUALCOMM; Solomon Trujillo, CEO, Telstra; Moderator: Stephanie Mehta, FORTUNE

 

10:50 am—11:00 am – “MY MEME” - Kevin Lynch, Chief Software Architect, Adobe Systems; Vineet Nayar, President, HCL Technologies

 

11:00 am—11:30 am – BREAK

         

ONC    11:30-12:30 - CONCURRENT BREAKOUT SESSIONS: I. Green Car of the Future - Martin Eberhard, CEO, Tesla Motors; Steve Fambro, CEO, Aptera Motors; Amory Lovins, Co-founder, Chairman, and Chief Scientist, Rocky Mountain Institute; Bill Reinert, National Manager, Advanced Technologies Group, Toyota; Moderator: Brian Dumaine, FSB: Fortune Small Business; II. Why Online Identity and Trust are Critical to Economic Growth Kim Cameron, Architect of Identity and Access, Microsoft; Louise Guay, President, My Virtual Model; Chris Kelly, Chief Privacy Officer, Facebook; Harriet Pearson, VP, Regulatory Policy, and Chief Privacy Officer, IBM; Paul Trevthick, CEO and Co-founder, Parity Communications; Moderator: John Clippinger, Senior Fellow, Berkman Center for Internet & Society, Harvard Law School; III. Crowdsourcing: How Communities Change Media, Marketing, and Making Money - Richard Barton, CEO, Zillow.com; Jim Buckmaster, CEO, craigslist; Max Levchin, CEO, Slide; Jeremy Stoppelman, CEO, Yelp; Moderator: Jeffrey O’Brien, FORTUNE

 

12:30 pm—2:00 pm – LUNCH BREAK

 

2:00 pm—2:05 pm – “MY MEME” - Geordie Rose, Founder and CTO, D-Wave Systems

 

2:05 pm—2:20 pm – THE 21ST CENTURY CEO: NEW TECHNOLOGIES, SHIFTING CULTURE - Jonathan Schwartz, CEO, Sun Microsystems; Interviewer: David Kirkpatrick, FORTUNE

 

2:20 pm – 3:05 pm – SUPER NATURAL SELECTION: WHAT’S NEXT FOR THE GIANTS OF ONLINE MEDIA? - Jim Lanzone, CEO, Ask.com; Yusuf Mehdi, Senior VP and Chief Advertising Strategist, Microsoft; Sheryl Sandberg, VP, Global Online Sales and Operations, Google; Jeff Weiner, Executive Vice President, Yahoo!; Moderator: Adam Lashinsky, FORTUNE

 

3:05 pm—3:15 pm – “MY MEME” - John Chambers, CEO, Cisco Systems; Introduced by David Kirkpatrick, FORTUNE

 

3:15 pm—4:00 pm – iMEME: THRIVE – TAPPING TECH’S GLOBAL OPPORTUNITY - John Chambers, CEO, Cisco Systems; John Gage, Chief Researcher, Sun Microsystems; Bernard Liautaud, Founder, Chairman, and Chief Strategy Officer, Business Objects SA; Padmasree Warrior, CTO, Motorola; Moderator: Rik Kirkland, FORTUNE

 

4:00 pm—4:05 pm – “MY MEME” - Gary Flake, Technical Fellow, Microsoft

 

4:05 pm—4:30 pm – BREAK

 

4:30 pm—5:30 pm – CONCURRENT BREAKOUT SESSIONS: I. HyperEvolution: Merging Man and Machine—The Intersection of IT and Biology - Robin Abrams, Chairman, Emotiv Systems; John Donoghue, Director, Brain Science Program, Brown University; Tomaso Poggio, Investigator, McGovern Institute for Brain Research, MIT; Craig Venter, President, J. Craig Venter Institute; Moderator: Brian O’Keefe, FORTUNE; II. The Next Four Billion - Allen Hammond, Vice President, Special Projects and Innovation, Markets and Enterprise Program, World Resources Institute; Karishma Kiri, Director, Market Expansion Group, Microsoft; Dan Shine, Director, 50X15 Initiative, AMD; Lee Thorn, Chair, Jhai Foundation; Moderator: Katie Benner, FORTUNE; III. The Future of Enterprise Software – Mark Carges, Executive Vice President, Business Interaction Division, BEA Systems; Mark Lewis, Executive Vice President and Chief Development Officer, EMC; Bernard Liautaud, Founder, Chairman, and Chief Strategy Officer, Business Objects SA; Doug Merrit, Executive Vice President and General Manager, SAP; Zach Nelson, CEO, NetSuite; Moderator: Endre Holen, Director and Leader, North American Technology Sector, McKinsey

 

5:30 pm—6:00 pm – BREAK

 

6:00 pm—7:00 pm – COCKTAIL RECEPTION

 

7:00 pm—7:45 pm – PANEL DISCUSSION: THE NEXT MEMES - Richard Dawkins, Professor, New College, Oxford University; Bill Joy, Partner, Kleiner Perkins Caufield & Byers; Craig Venter, President, J. Craig Venter Institute; Moderator: Andy Serwer, FORTUNE

 

 

Time:   Friday, July 13

 

7:00 am – PRESS REGISTRATION OPENS

 

7:30 am—8:20 am – DAY ONE RETROSPECTIVE – Hosted by BT; Leader: David Kirkpatrick,    FORTUNE; Special Guests: Michael Boustridge, President, BT Americas; Colin Spence, COO,        BT Americas; Paul Stitch, President and CEO, BT Counterpane; Julie Woods-Moss, Vice President, Marketing, BT Global Services

 

8:30 am—9:30 am – I. Lessons of the Digital Media Revolution; Lauren Berkowitz, Senior Vice President, Digital, EMI Music North America; Robert Glaser, CEO, RealNetworks; Jerry Harrison, Talking Head and Chairman, iLike; Terry McBride, CEO, Nettwerk Music Group; Shane Robison, Chief Strategy and Technology Officer, Hewlett-Packard; Moderator: Devin Leonard, FORTUNE; II. Nothing Ventured, Nothing Gained in the Digital Vortex: VC’s Talk About the Facts of Life in the New Tech Economy - Jim Breyer, General Partner, Accel Partners; Michael Moritz, General Partner, Sequoia Capital; Jerry Murdock, Managing Director, Insight Venture Partners; Fred Wilson, Founding Partner, Union Square Ventures; Moderator: Adam Lashinsky, FORTUNE

 

9:30 am—9:45 am – BREAK

 

9:45 am—9:50 am – “MY MEME” - Esther Dyson, EDventure Holdings/Release 0.9

 

9:50 am—10:35 am – iMEME: OPEN - NEW WORLD ORDER - Mitchell Baker, CEO, Mozilla; Mitchell Kapor, Founder, Kapor Enterprises; Jimmy Wales, Chairman, Wikimedia Foundation; Moderator: John Markoff, The New York Times

 

10:35 am—10:40 am – “MY MEME” - Eva Chen, CEO, Trend Micro

 

10:40 am—11:00 am –BREAK

 

11:00 am—11:20 am – THE NEXT PHASE: A VIEW FROM THE 22nd CENTURY - Vinton Cerf, Chief Internet Evangelist, Google; Interviewer: David Kirkpatrick, FORTUNE

 

11:20 am—11:25 am – “MY MEME” - Stuart Wells, SVP & President, Global Communications Solutions, Avaya

 

11:25 am—12:10 pm – iMEME: NET MUTATIONS - THE FUTURE OF MEDIA - Samir Arora, CEO, Glam Media; Beth Comstock, President, Integrated Media, NBC Universal; Michael Jackson, President of Programming, IAC; Bruno Zheng Wu, Chairman, Sun Media Investment Holdings Group of Companies;  Moderator: Oliver Ryan, FORTUNE

 

12:10 pm—12:20 pm – “MY MEME” – Hal Raveché, President, Stevens Institute of Technology; Michael Boustridge, President, BT Americas

 

12:20 pm—12:45 pm – HOW HP RIGHTED THE SHIP: AN INTERVIEW WITH MARK HURD - Mark Hurd, Chairman & CEO, Hewlett-Packard; Interviewer: Adam Lashinsky, FORTUNE

 

12:45 pm – CLOSING REMARKS - Andy Serwer, FORTUNE; David Kirkpatrick, FORTUNE

 

Editorially sponsored by FORTUNE’s technology, media, and Internet editorial talent and chaired by technology editor David Kirkpatrick, iMEME’s major corporate sponsors include: Avaya, BT, Herman Miller, and The NASDAQ Stock Market, Inc.; Knowledge Partner: McKinsey & Company; and Supporters: Yoomba and spigit, Inc.  

 

For additional information, please visit:

http://www.timeinc.net/fortune/conferences/imeme/imeme_home.html